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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This is a US study comparing the efficacy and safety of BDA MDI [Budesonide/Albuterol Sulfate (BDA) metered dose inhaler (MDI)] with AS [Albuterol Sulfate] MDI, both are administered as needed for up to 12 months.
This is a phase IIIb, multicenter, randomized, double-blind, parallel-group, event-driven, variable-length, decentralized study.
Participants from around 40 to 50 centers located in the US will be screened and randomized 1:1 to receive one of the following two treatments to be used as needed: BDA MDI (160/180 μg) and AS MDI (180 μg). Participants 12 years of age and older with asthma will be recruited with all visits conducted virtually.
Eligible participants must be using as-needed SABA (Short -acting β2agonist) alone, or as-needed SABA on a background of either low-dose ICS (Inhaled corticosteroid) or a LTRA (Leukotriene receptor agonist), for the treatment of asthma.
Participants will be stratified by pre-study asthma medication (SABA only, low-dose ICS + SABA and LTRA + SABA) and number of prior severe exacerbations (0, ≥1) in the 12 months prior to the Screening visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT027 | Experimental | Participants will receive Budesonide and Albuterol Sulfate Pressurised Inhalation Suspension 160/180 μg up to a maximum of 12 inhalations to max dose. |
|
| PT007 | Experimental | Participants will receive Albuterol Sulfate Pressurised Inhalation Suspension 180 μg up to a maximum of 12 inhalations to max dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDA MDI | Drug | Participants will receive Budesonide and Albuterol Sulfate MDI 80/90 μg per Actuation 1 to 6 doses (2 inhalations/dose) per day as needed via Oral inhalation route. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Severe Asthma Exacerbation, While on Treatment Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of the first severe asthma exacerbation event. Participants were censored at treatment discontinuation, a step-up in maintenance therapy, or interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The primary outcome measure was analyzed at the interim analysis (22 April 2024). Since the primary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported. | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation, step-up in maintenance therapy, or interim analysis DCO, up to one year following treatment initiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation occurred. Participants were censored at study completion or withdrawal, or the interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The key secondary outcome measure was analyzed at the interim analysis (22 April 2024). Since the key secondary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig LaForce, MD | North Carolina Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates of Mobile PC | Mobile | Alabama | 36608 | United States | ||
| One of a Kind Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40388330 | Derived | LaForce C, Albers F, Danilewicz A, Jeynes-Ellis A, Kraft M, Panettieri RA Jr, Rees R, Bardsley S, Dunsire L, Harrison T, Sobande O, Surujbally R, Trudo F, Cappelletti C, Papi A, Beasley R, Chipps BE, Israel E, Pandya H, Clancy M, Bacharier LB; BATURA Investigators. As-Needed Albuterol-Budesonide in Mild Asthma. N Engl J Med. 2025 Jul 10;393(2):113-124. doi: 10.1056/NEJMoa2504544. Epub 2025 May 19. |
| Label | URL |
|---|---|
| Study Design Publication | View source |
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A total of 5,221 participants were screened for this study, of which 2,516 participants were randomized to treatment; 2,705 were ineligible for participation in the trial. Of the 2,516 participants randomized, the full analysis set (ages 12 years and above) comprised of 2,421 participants as 95 participants discontinued the study prior to dosing randomized treatment.
The first participant was screened on 2 September 2022. Participants were enrolled at 54 sites in the United States. Primary and first secondary objectives were tested at the interim analysis, on data collected up to 22 April 2024. Following the decision to stop the study early for overwhelming efficacy, participants were instructed to attend their end of study visits. The last participant last visit occurred on 22 August 2024 and final database lock was achieved on 20 September 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | BDA MDI (PT027) 160/180 μg | Budesonide/albuterol sulfate, BDA MDI, PT027 Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol |
| FG001 | AS MDI (PT007) 180 µg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 5, 2024 | Feb 28, 2025 |
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| AS MDI | Drug | Participants will receive Albuterol Sulfate MDI 90 μg per Actuation 1 to 6 doses (2 inhalations/dose) per day as needed via Oral inhalation route. |
|
| From treatment initiation until the earliest occurrence of study completion or withdrawal only, regardless of treatment discontinuation, a step-up in maintenance therapy or interim analysis DCO, up to one year following treatment initiation. |
| Time to First Severe Asthma Exacerbation, While on Treatment Strategy (Participants Aged >=18 Years) | The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Participants were censored at treatment discontinuation or a step-up in maintenance therapy. An asthma exacerbation was considered severe if it results in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported. | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
| Time to First Severe Asthma Exacerbation, Treatment Policy Strategy (Participants Aged >=18 Years) | The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the Final DCO (20 September 2024). Participants were censored at study completion or withdrawal. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported. | From treatment initiation until the earliest occurrence of study completion or withdrawal only, regardless of treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
| Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=12 Years) | The annualized exacerbation rate was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
| Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=18 Years) | The annualized exacerbation rate was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
| Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years) | The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis. | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
| Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years) | The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis. | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
| Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years) | The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis. | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
| Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years) | The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis. | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
| Paradise Valley |
| Arizona |
| 85253 |
| United States |
| Fiel Family and Sports Medicine/CCT Research | Tempe | Arizona | 85283 | United States |
| Kern Research Inc. | Bakersfield | California | 93301 | United States |
| Science 37 | Culver City | California | 90230 | United States |
| Antelope Valley Clinical Trials | Lancaster | California | 93534 | United States |
| Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology | San Diego | California | 92123 | United States |
| Clinical Research of California | Walnut Creek | California | 94598 | United States |
| Asthma and Allergy Associates | Colorado Springs | Colorado | 80907 | United States |
| Velocity Clinical Research, Denver | Denver | Colorado | 80209 | United States |
| Helix Biomedics | Boynton Beach | Florida | 33435 | United States |
| Allergy and Asthma Diagnostic Treatment Center | Tallahassee | Florida | 32308 | United States |
| Centricity Research | Columbus | Georgia | 31904 | United States |
| Centricity Research | Columbus | Georgia | 31905 | United States |
| Centricity Research | Columbus | Georgia | 31906 | United States |
| Centricity Research | Columbus | Georgia | 31907 | United States |
| Lifeline Primary Care | Lilburn | Georgia | 30047 | United States |
| Javara Inc./Privia Medical Group Georgia, LLC | Savannah | Georgia | 31406 | United States |
| Velocity Clinical Research - Boise | Meridian | Idaho | 83642 | United States |
| Velocity Clinical Research - Valparaiso | Valparaiso | Indiana | 46383 | United States |
| Velocity Clinical Research | Lafayette | Louisiana | 70508 | United States |
| Javara Inc. | Annapolis | Maryland | 21401 | United States |
| Baltimore Early Phase Clinical Unit (EPCU) | Baltimore | Maryland | 21225 | United States |
| Chesapeake Clinical Research | White Marsh | Maryland | 21162 | United States |
| Genesis Clinical Research and Consulting, LLC | Fall River | Massachusetts | 02723 | United States |
| Infinity Medical Research | North Dartmouth | Massachusetts | 02747 | United States |
| Mankato Clinic | Mankato | Minnesota | 56001 | United States |
| Spectrum Clinical Research | Kansas City | Missouri | 64118 | United States |
| Meridian Clinical Research, LLC | Lincoln | Nebraska | 68510 | United States |
| Midwest Regional Health Services, LLC/CCT Research | Omaha | Nebraska | 68144 | United States |
| Meridian Clinical Research | Endwell | New York | 13760 | United States |
| Modern Migraine MD/CTNX | New York | New York | 10001 | United States |
| Javara Inc. | Charlotte | North Carolina | 28277 | United States |
| Javara Inc/Wake Forest Health Network, LLC | Clemmons | North Carolina | 27012 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Wilmington Health (Innovo Research) | Wilmington | North Carolina | 28401 | United States |
| Buckeye Health and Research | Columbus | Ohio | 43207 | United States |
| Velocity Clinical Resarch - Medford | Medford | Oregon | 97504 | United States |
| Northwest Research Center | Portland | Oregon | 97202 | United States |
| Hatboro Medical Associates | Hatboro | Pennsylvania | 19040 | United States |
| Velocity Clinical Research - Providence | East Greenwich | Rhode Island | 02818 | United States |
| AAPRI Clinical Research Institute | Warwick | Rhode Island | 02886 | United States |
| CVS Health | Woonsocket | Rhode Island | 02895 | United States |
| CVS Health | Woonsocket | Rhode Island | 02896 | United States |
| CVS Health | Woonsocket | Rhode Island | 02897 | United States |
| CVS Health | Woonsocket | Rhode Island | 02898 | United States |
| CVS Health | Woonsocket | Rhode Island | 02899 | United States |
| CVS Health | Woonsocket | Rhode Island | 02900 | United States |
| Velocity Clinical Research - Anderson | Anderson | South Carolina | 29621 | United States |
| Velocity Clinical Research, Greenville | Greenville | South Carolina | 29615 | United States |
| Velocity Clinical Research, Austin | Cedar Park | Texas | 78759 | United States |
| Privia Medical Group Gulf Coast | Cypress | Texas | 77433 | United States |
| CardioVoyage LLC | Denison | Texas | 75020 | United States |
| Texas Health Care, PLLC d/b/a Privia Medical Group- North Texas | Fort Worth | Texas | 76133 | United States |
| Allure Health at Mt Olympus Medical Research | Friendswood | Texas | 77546 | United States |
| LinQ Research, LLC | Pearland | Texas | 77584 | United States |
| Mt. Olympus Medical Research | Sugar Land | Texas | 77479 | United States |
| South Ogden Family Medicine clinic | Ogden | Utah | 84405 | United States |
| Velocity Clinical Research -Salt Lake City | West Jordan | Utah | 84088 | United States |
| Meridian Clinical Research | Portsmouth | Virginia | 23703 | United States |
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
| Full Analysis Set; >=12 Years |
|
| Full Analysis Set; >=18 Years |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BDA MDI (PT027) 160/180 μg | Budesonide/albuterol sulfate, BDA MDI, PT027 Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol |
| BG001 | AS MDI (PT007) 180 µg | Albuterol sulfate MDI, PT007 Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to First Severe Asthma Exacerbation, While on Treatment Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of the first severe asthma exacerbation event. Participants were censored at treatment discontinuation, a step-up in maintenance therapy, or interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The primary outcome measure was analyzed at the interim analysis (22 April 2024). Since the primary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported. | Full analysis set; >=12 years | Posted | Count of Participants | Participants | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation, step-up in maintenance therapy, or interim analysis DCO, up to one year following treatment initiation. |
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| Secondary | Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years) | The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation occurred. Participants were censored at study completion or withdrawal, or the interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The key secondary outcome measure was analyzed at the interim analysis (22 April 2024). Since the key secondary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported. | Full analysis set; >=12 years | Posted | Count of Participants | Participants | From treatment initiation until the earliest occurrence of study completion or withdrawal only, regardless of treatment discontinuation, a step-up in maintenance therapy or interim analysis DCO, up to one year following treatment initiation. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Severe Asthma Exacerbation, While on Treatment Strategy (Participants Aged >=18 Years) | The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Participants were censored at treatment discontinuation or a step-up in maintenance therapy. An asthma exacerbation was considered severe if it results in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported. | Full analysis set; >=18 years | Posted | Count of Participants | Participants | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Severe Asthma Exacerbation, Treatment Policy Strategy (Participants Aged >=18 Years) | The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the Final DCO (20 September 2024). Participants were censored at study completion or withdrawal. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported. | Full analysis set; >=18 years | Posted | Count of Participants | Participants | From treatment initiation until the earliest occurrence of study completion or withdrawal only, regardless of treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
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| Secondary | Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=12 Years) | The annualized exacerbation rate was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. | Full analysis set; >=12 years | Posted | Number | 95% Confidence Interval | events per year | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
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| Secondary | Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=18 Years) | The annualized exacerbation rate was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. | Full analysis set; >=18 years | Posted | Number | 95% Confidence Interval | events per year | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years) | The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis. | Full analysis set; >=12 years | Posted | Mean | Full Range | mg/year | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years) | The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis. | Full analysis set; >=18 years | Posted | Mean | Full Range | mg/year | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years) | The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis. | Full analysis set; >=12 years | Posted | Mean | Standard Deviation | days | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years) | The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis. | Full analysis set; >=18 years | Posted | Mean | Standard Deviation | days | From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation. |
|
All-cause mortality (death due to any cause): from randomization up to and including the final DCO (20 September 2024) or study discontinuation, up to 1 year. Treatment-emergent adverse events: from treatment initiation until the earliest occurrence of study completion or treatment discontinuation, up to 1 year.
All-cause mortality was reported for all participants, one reported death occurred post-randomization before first dose of study drug. Adverse events were reported for participants who received at least one dose of study drug, and includes AEs from treatment initiation until the earliest occurrence of study completion or treatment discontinuation.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BDA MDI (PT027) 160/180 μg | Budesonide/albuterol sulfate, BDA MDI, PT027 Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg: Budesonide/albuterol sulfate combination inhalation aerosol | 2 | 1,257 | 37 | 1,209 | 227 | 1,209 |
| EG001 | AS MDI (PT007) 180 µg | Albuterol sulfate MDI, PT007 Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol | 1 | 1,259 | 37 | 1,212 | 232 | 1,212 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Metapneumovirus pneumonia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vitamin B complex deficiency | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Schizoaffective disorder bipolar type | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Middle cerebral artery stroke | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (27.0) | Systematic Assessment |
| |
| Adnexal torsion | Reproductive system and breast disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Drug screen positive | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Oophorectomy | Surgical and medical procedures | MedDRA (27.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
|
Data or results obtained from this study must not be published without prior approval from the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avillion Life Sciences | +44 (0)203 764 9530 | contact@avillionls.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2024 | Feb 28, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or other Pacific Islander |
|
| American Indian or Alaska Native |
|
| Multiple |
|
| Other |
|
| Not Reported |
|
| Missing |
|
| OG001 | AS MDI (PT007) 180 µg | Albuterol sulfate MDI, PT007 Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol |
|
|
|
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
|
|
Albuterol sulfate MDI, PT007
Albuterol sulfate metered-dose inhaler 180 μg: Albuterol sulfate inhalation aerosol
|
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